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A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions

NCT06266988 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-02-20

No results posted yet for this study

Summary

Primary objective is to is to evaluate the bioequivalence of two formulations

Conditions

Interventions

DRUG

Sacubitril and Valsartan Tablets 97mg/103mg

Each Tablet contains 97 mg of Sacubitril and 103 mg of Valsartan

DRUG

Entresto (Sacubitril and Valsartan Tablets 97mg/103mg)

Each Tablet contains 97.2 mg sacubitril and 102.8 mg valsartan as sodium salt complex

Sponsors & Collaborators

  • Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Ariya Khunvichai, Ph.D · Medica Innova Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2024-04-30
Completion
2024-08-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06266988 on ClinicalTrials.gov